SMART-TRIAL Annual User Summit
Tailored to your organisation
Our customer success team will help you take the first step in using the platform. From there on, you can setup and manage studies in SMART-TRIAL all by yourself.
User Onboarding is mandatory for all licenses and includes consultancy and help with study set-up to reduce the time of implementation.See our references »
Designed to support your continuous clinical evaluation process.
A team that supports your clinical data strategy with industry know-how.
Services and features that adhere to medical device manufacturers.
The SMART-TRIAL services and technology are both new and different compared to what you might be used to. To ensure that you get the most out of the platform, an onboarding program is required to ensure a successful start. This includes training and consultation in setup, planning, eCRF and process design, and help with set-up of your first studies in SMART-TRIAL. Contact us to learn how you can gain the most value from our User Onboarding.
SMART-TRIAL is a web-based software as a service (SaaS) solution that requires no specific implementation or installation. SMART-TRIAL is accessible in most modern browsers and is built on modern technology that makes it possible to access on most devices through an internet browser.
SMART-TRIAL is a “do it yourself” solution. This means that after you’ve completed onboarding, you can setup everything by yourself – it doesn’t require any programming knowledge. You can use the ready-to-use modules to set up your study for eCRF, ePRO, or both. Create forms, processes, and sites, by using a drag-and-drop interface.
With SMART-TRIAL you can choose to archive your study if you don’t need to collect data anymore. That is, you can keep all your study data safely stored in one place for as long as you wish. When your study is archived, you can only export data and review your setup, but you don’t have to pay any license fees. Please note: archiving is not for free if you require more than 1GB storage. You will have to continue paying for your data hosting. Contact us for further pricing enquiries.
Yes, we do provide a service to migrate older data to SMART-TRIAL. However, it's highly dependent upon the format, type of previous storage, access to data, etc. Contact us and we’ll see what we can do.
SMART-TRIAL is designed controlled according the IEC62304 and ISO13485 quality standards and hosted in a certified environment by Microsoft Azure. We have a complete set of SOPs and tools to ensure both stable work environment, and secure data storage. Read more about the security & quality' and take a look at the Security & Service Statement, and the GCP, HIPAA, CFR21 statement.
There's no limit on the number of users, sites, processes, forms, or subjects. For all SMART-TRIAL licenses we include both email and telephone support, all mandatory software updates and any additional updates to the software, along with continuous backups and 99,95% promised uptime and availability.
The SMART-TRIAL eCRF license gives you access to eCRF feature (visit events), where users can log in and enter data into an electronic case report form. You also get access to clinical trial features like queries, the AE/SAE module, medication log (for concomitant medications and/or IMP) module, and medication accounting module.
SMART-TRIAL ePRO/Survey license gives you access to ePRO/Survey (subject events), where you can send questionnaires to subjects via e-mail and SMS, create a survey, or combine both in a long-term process. 1.000 standard length (128 Alphanumeric characters) SMS are included every month. You can buy more SMS if you need.
Single-study licenses are always presented as a price per study per month. All licenses, with any additional modules, are billed up front for the upcoming month, or beforehand for the total number of months required. SMART-TRIAL multi-volume license packages are billed up front for the upcoming 12 months.
All licenses include email and telephone support. Support is provided for all SMART-TRIAL users, from sponsor, monitors, to all site(s) staff (investigators etc.) – but not patients/subjects. Standard service hours are from 9.00 to 17.00 Monday through Friday and Sunday from 12.00 to 16.00 (CET Copenhagen).